Are you familiar with the devastating impact that neurodegenerative, autoimmune, and metabolic diseases can have on patients’ lives? These conditions often leave individuals feeling hopeless and helpless. But what if there was a company solely dedicated to developing innovative therapies for these serious illnesses? In this Interview with TechBullion, Howard Berman, Ph.D., CEO of Coya Therapeutics, shares with us more insights on how the company is meeting the significant medical needs of patients through cutting-edge therapeutic approaches.
Please tell us a little more about yourself?
My name is Howard Berman and I am the CEO and Founder of Coya Therapeutics. I have a scientific background with a Ph.D. in neuropharmacology from Weill Cornell Medical School. My career has spanned over 20 years developing, commercializing, and launching drugs at multiple pharmaceutical companies in increasing roles and responsibilities.
My path to founding Coya originated with my ailing father. This brilliant man, a triple board certified physician, was on an incessant cognitive decline and I had pulled every string to get him into the Houston Methodist Hospital into the capable hands of world renowned neurologist, Dr. Stanley Appel. Dr. Appel was a legend in neurological circles – the thought leader that thought leaders turn to. I loved my father with all my might and if there was one person that could help, it was Dr. Appel. Sadly, Dr. Appel informed me that a dementia diagnosis has no viable treatments and that my father would be on standard of care, meaning drugs that might slow the decline a small amount, but there would continue to be progressive disease. As I was leaving his office, Dr. Appel commented, “But, we have exciting new data from an investigational approach that downregulates neuroinflammation, via a pathway called the Regulatory T cell (or Treg). And this approach has begun to show dramatic results in a number of patients with Alzheimer’s Disease and ALS, diseases that are driven by inflammatory processes.” He wanted to know if I was interested in learning more?
A week later, I sat in Dr. Appel’s office peering at some of the most remarkable data that I had seen in neurodegenerative diseases. My natural skepticism had evolved following my Phd in neuropharmacology from Weill Cornell and my many years of drug development experience in the pharmaceutical industry. Dr. Appel had early clinical data that demonstrated that Tregs, a white blood cell that inhibits inflammation, were dysfunctional in ALS and Alzheimer’s Disease and that the heightened inflammation was in part responsible for the continued decline and survival of the patients. The inflammatory processes were getting the neurons into trouble and resulting in a positive feedback cycle much like a raging forest fire. In early clinical trials, using both biologic drugs and cell therapy, Dr. Appel had seemingly shown he could halt the progression of these diseases. “Would I be interested to help him commercialize these programs,” he asked?
From that day forward, I was committed to bringing these therapies to patients, and selfishly, I wanted my father to have an opportunity to try something unique. Over the next two years, I built Coya Therapeutics into a multi-pipeline biotech company with biologic and cell therapy programs to enhance dysfunctional Tregs in neurodegenerative diseases. Multiple clinical trials have shown tremendous promise for Treg therapies in ALS and Alzheimer’s Disease with the potential ability to stop disease progression and even improve function in some cases. Based on these early successes, the time to raise a significant round of financing had arrived in order that we enter into a larger, well controlled clinical trial, one that my father could participate in. On the week that Coya successfully completed its IPO, sadly, my father lost his battle to dementia. He couldn’t hold on for the next trial, but I am committed to bringing forward the vision of Dr. Appel and Treg therapies so other families do not have to experience the same heartbreak.
What is Coya Therapeutics, could you tell us more about your company and your mission?
Coya Therapeutics is a public biotechnology company, and our mission is to bring meaningful solutions for patients suffering from devastating neurodegenerative diseases like Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s Disease, and other diseases where inflammation is an underlying disease driver. Multiple lines of research have identified inflammation, both within the brain and peripherally in the rest of the human body, as a potential driver of these conditions. Heightened inflammation and associated oxidative stress drive neuronal damage and may lead to progressive decline of the patient’s condition. An important cell type in the blood, the regulatory T cells (Treg), turns out to be a critical contributor to the increased inflammatory process when these cells are dysfunctional. These Tregs are an important cell type in the body responsible for dampening inflammation. In multiple disease conditions, we have discovered that Tregs are compromised and dysfunctional, and that developing therapeutics to enhance Tregs function and numbers is a potentially revolutionary approach to stem the inflammatory cascade driving these diseases. Our lead candidate, COYA 302, is a biologic combination immunotherapy that targets two aspects of the dysfunctional immune system driving many of these conditions.
One of the component drugs is low dose IL-2 that is our own proprietary low dose formulation of this cytokine protein. This drug, when administered subcutaneously at a specific dose and frequency, selectively upregulates the Treg function and numbers. The other component drug is CTLA4-Ig, a fusion protein that suppresses and inhibits the pro-inflammatory cell types in the body (called macrophages), that play an important role in deactivating Tregs as well as releasing toxic substances that are damaging to neurons. These two drugs, when administered together, appear to have synergistic activity in suppressing inflammation and ramping up Treg function. Much like HIV/AIDS and Oncology, we believe that combination therapies are best suited to addressing these complex disease conditions, which involve multi-factorial pathways.
We feel encouraged that we are making great progress in realizing our mission with COYA 302. Early clinical proof-of-concept clinical data in patients with ALS, who were declining prior to treatment initiation, showed a halting of disease progression up to 24 weeks with minimal decline out to 48 weeks with increased Treg function over the entire 48 week treatment period. These results are exciting given the fact that patients typically decline on a monthly basis and the approved drugs don’t halt progression, they merely slow it by a small amount. Of course, we will plan on running a larger, well controlled, clinical trial to validate these results so that we can show the regulators. Moreover, we have discovered blood based biomarkers that appear to correlate nicely with the patient’s response and are considering a way to incorporate this into our next trial.
We will also be presenting data from another clinical Proof-of-Concept study in Alzheimer’s disease at an upcoming medical conference on May 16th, 2023. We are excited to illustrate the role that our biologics can have in multiple neurodegenerative and autoimmune diseases going forward.
Could you give us more insights into neurodegenerative diseases and how they are affecting the human race?
Of all the afflictions that can affect people as they grow older, neurodegenerative disease is one of the most devastating. Parkinson’s disease (PD), Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease) and related conditions affect not only the individual, but everyone near and dear to them and in the cruelest way imaginable, as these diseases devastate the mind and body. Families are forced to watch in real time the loss of the personality or identity of their loved one. Unfortunately, with my father’s condition and loss, I was one of those family members. In 2019, roughly 50 million people globally had a neurodegenerative condition with this figure predicted to rise to 152 million by 2060. Unfortunately, there are no cures with few to no effective treatments. The current estimated annual cost to American society of just nine of the most common neurological diseases is staggering, totaling approximately $800 billion with mounting costs as the elderly segment of the population nearly doubles by 2050. There is an urgent need to find therapeutics that can either slow or stop the disease progression. We believe that our approach targeting Tregs and inflammation is a real new step in addressing this serious problem.
Could you give us a market overview of this healthcare industry, the market size, trends influencing innovations in this industry and what to expect in the future?
Most of us know someone affected by Alzheimer’s disease and other forms of dementia. It’s a disease that takes a serious toll on the patient, but also on the family members. In the US alone, it is estimated there are >6 million patients suffering from Alzheimer’s Disease and globally the estimates are close to 50 million patients. The future in the treatment of these neurodegenerative diseases will likely be combination approaches that address multiple factors.
In ALS, every year there are approximately 5000 patients diagnosed and ~ 30,000 treatable patients. The commercial potential for neurodegenerative therapies is attractive as there are very limited options today and many patients await better options.
Who would benefit from the therapies developed by Coya Therapeutics, how far along is Coya Therapeutics in clinical trials for their therapies and are there any side effects associated with your therapies?
Patients suffering from neurodegenerative diseases like ALS and Alzheimer’s disease and other dementias are where we are currently doing our clinical work, so these will be the first group of patients likely to benefit if we are successful with our registrational trials and get regulatory approval. We also have an interest in autoimmune conditions, which may also benefit from our approach in modulating inflammation. We always closely monitor safety in all our clinical studies and of course will work closely with the FDA and other regulatory agencies to ensure new therapies are safe and effective.
Would you like to share some of your success stories so far, are there any upcoming developments or breakthroughs that we can expect from your company within the next year or so?
We are very excited by the promising proof of concept clinical results we have seen in our ALS trial using COYA 302, the biologic combination immunotherapy. This data, which showed a halting of progression, and which was well tolerated has provided us confidence to advance COYA 302 to a larger, well controlled clinical trial by the end of 2023.
In addition, we will be sharing results from our early clinical study in Alzheimer’s disease in mid-May using our biologic immunotherapy.
Could you tell us more about your team and the brains behind your developments at Coya Therapeutics, what makes you the best in this industry?
Let’s start with our scientific bona fides. We’re building Coya on the foundation of a deep understanding of the role of regulatory T-cells in disease. Who better to have on our team than Shimon Sakaguchi who first discovered regulatory T cells? We are honored by his commitment. He’s on many short lists for the Nobel Prize for this discovery. Dr. Stan Appel leads our scientific advisory board. Dr. Appel is a researcher and clinician of great distinction. His lab has pioneered the role of dysfunctional Tregs in neurological and autoimmune disorders. We are the beneficiary of the important clinical work Dr. Appel and his team of young investigators has performed in both primary cell therapeutics and in the biologic combinations which today Coya finds so promising. We also believe Dr Appel’s far-reaching reputation will be critical as we recruit additional investigators and patients to our upcoming clinical trial of Coya 302.
But for sure we need to drive our programs through a clinical/regulatory process and into the hands of patients in need. To that end we’re thrilled that Dr. Adrian Hepner is on our team as President and Chief Medical Officer. Adrian has had a long career as both a clinician and in pharmaceutical leadership in the field of neurological and autoimmune diseases. Most important for us, he knows how to get drugs out of the lab and through a clinical process. Adrian knows how to execute and has done so repeatedly, most recently at Avanir Pharmaceuticals where he helped get Nuedexta through the clinical development process and approved for patients.
Next we needed to finance the company appropriately for long term success and manage it well as a first-class operating business. David Snyder joined us as CFO and COO. David has now helped lead five companies through their private to public transition and has been the CFO of four public companies. Like Adrian, he’s a seasoned executive with long experience in strategy and operations of entrepreneurial life science companies.
Most recently we’re excited that Arun Swaminathan has joined the team as Chief Business Officer. We believe our technology has wide applicability and frankly we won’t be able to pursue every promising therapeutic idea. We look forward to entering into partnerships where we can use both our biologic assets and our exosome platform in joint pursuit with other pharma companies of a novel therapeutic indication. While BD deals do provide an important source of non-dilutive funding, they also provide a critical way of leveraging our technology for the benefit of patients in need. Arun, has deep experience in just this kind of business development process. Just like Adrian and David, Arun knows how to execute and has done so repeatedly over a 20-year career. While at Alteogen Arun spearheaded over $6 billion in transactions. That’s an ambitious number for Coya but we’re optimistic that we’ll see exciting progress in the months ahead.
Lastly, and at the risk of being immodest, I think I’m very well equipped to lead this team. I’m a PhD by training, a long-term pharmaceutical executive by practice and an entrepreneur at heart. We’ve identified a compelling opportunity, devised a clear strategy, and married both with the financial resources and personnel to drive success.
Do you have any available opportunities for investment and partnerships to enable your works at Coya Therapeutics, any more tips to share with our readers?
We are a public company listed on NASDAQ, stock symbol “COYA”, so anyone can participate in investing through the purchase of our common shares on the public market. Our current cash runway will take us through mid-2024 and across multiple catalysts and milestones. Simultaneously, we are also actively seeking strategic biopharma partners that can collaborate and drive additional support for our multiple pipeline assets.